# FDA recall D-0595-2026

> **Haleon US Holdings LLC** · Class I · drug recall initiated 2026-06-04.

## Product

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.

## Reason for recall

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0595-2026
- **Recalling firm:** Haleon US Holdings LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-06-04
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0595-2026

## Citation

> AI Analytics. FDA recall D-0595-2026. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0595-2026. Source: US FDA. Licensed CC0.

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